Trial Outcomes & Findings for Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic Ulcer (NCT NCT02418312)

NCT ID: NCT02418312

Last Updated: 2019-03-11

Results Overview

Follow-up endoscopy was performed at the end of the 6th month

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 228 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-03-11

Participant Flow

Participant milestones

Measure	Histamine-2 Receptor Antagonist Group famotidine 40mg qd for 6 months. histamine-2 receptor antagonist: famotidine 40 mg qd plus thienopyridine	Placebo Group placebo for 6 months. Placebo: placebo plus thienopyridine
Overall Study STARTED	114	114
Overall Study COMPLETED	114	114
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic Ulcer

Baseline characteristics by cohort

Measure	Histamine-2 Receptor Antagonist Group n=114 Participants famotidine 40mg qd for 6 months. histamine-2 receptor antagonist: famotidine 40 mg qd plus thienopyridine	Placebo Group n=114 Participants placebo for 6 months. Placebo: placebo plus thienopyridine	Total n=228 Participants Total of all reporting groups
Age, Continuous	72.7 years STANDARD_DEVIATION 11.9 • n=5 Participants	72.9 years STANDARD_DEVIATION 11.1 • n=7 Participants	72.8 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	36 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants	78 Participants n=7 Participants	164 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	114 Participants n=5 Participants	114 Participants n=7 Participants	228 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
history of smoking	14 participants n=5 Participants	10 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intention to treat

Follow-up endoscopy was performed at the end of the 6th month

Outcome measures

Measure	Histamine-2 Receptor Antagonist Group n=114 Participants famotidine 40mg qd for 6 months. histamine-2 receptor antagonist: famotidine 40 mg qd plus thienopyridine	Placebo Group n=114 Participants placebo for 6 months. Placebo: placebo plus thienopyridine
Number of Participants With Healed Peptic Ulcer	106 participants	101 participants

Adverse Events

Histamine-2 Receptor Antagonist Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Histamine-2 Receptor Antagonist Group n=114 participants at risk famotidine 40mg qd for 6 months. histamine-2 receptor antagonist: famotidine 40 mg qd plus thienopyridine	Placebo Group n=114 participants at risk placebo for 6 months. Placebo: placebo plus thienopyridine
Skin and subcutaneous tissue disorders skin rash	0.88% 1/114 • Number of events 1 • 6 months	0.00% 0/114 • 6 months
Gastrointestinal disorders persistent dyspepsia	0.88% 1/114 • Number of events 1 • 6 months	1.8% 2/114 • Number of events 2 • 6 months
Gastrointestinal disorders diarrhea	0.88% 1/114 • Number of events 1 • 6 months	0.00% 0/114 • 6 months

Additional Information

Dr. Ping-I Hsu

Kaohsiung Veterans General Hospital

Phone: +886-7-3422121

Email: pihsu@vghks.gov.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place